Be an early applicantLess than 25 applicantsPosted by Agency
Intellectt Inc ยท 2 days ago
Design Assurance Engineer
St Paul, MN
Full-time
Onsite
Mid Level
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Responsibilities
Ensure companies adherence to the established Quality System and GMP/ISO standards, including ongoing establishment and improvement to the quality system procedures.
Lead design assurance activities in support of development for electromechanical systems that utilize microcontroller technology, customized/off the shelf PCBs and software application.
Manage new product Design History Files.
Work with Engineering, Marketing, Manufacturing and Regulatory to establish measurable, valid product requirements.
Aide in definition of test equipment as required to accomplish quality responsibilities.
Develops and documents test plan protocols, test procedures, and test reports.
Perform tests according to various protocol requirements.
Lead completion of risk management and risk analysis including FMEA.
Devise design verification and design validation plans for products based on performance specifications and risk analysis
Analyze and communicate conformance to specifications and standards.
Conducts technical and statistical investigations concerning compliance to specification and optimization of design relevant to specification.
Support completion of in vitro testing including applicable animal studies.
Aide in definition of supplier quality specifications, sampling plans, and vendor qualification.
Assist in specifications and testing of sterilization methods.
Lead system and product continuous improvement teams.
Reviews Engineering Change Orders, as required.
Perform other duties and responsibilities as assigned by senior management.
Qualification
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Required
Bachelor's degree in Engineering or related field
Experience in quality assurance within a regulated industry (medical device, pharmaceutical, etc.)
Knowledge of GMP/ISO standards
Experience in electromechanical systems design
Experience with microcontroller technology and PCBs
Ability to develop and document test plans and procedures
Experience in risk management and analysis including FMEA
Ability to analyze and communicate conformance to specifications
Experience in supplier quality specifications and vendor qualification
Familiarity with sterilization methods
Strong communication and teamwork skills
Preferred
Experience with in vitro testing and animal studies
Experience in continuous improvement processes
Experience in regulatory affairs
Master's degree in Engineering or related field
Company
Intellectt Inc
Intellectt Inc. was founded to set a new standard in Consulting and Staffing Industry.
Founded in 2018
1,001-5,000 employees
H1B Sponsorship
Intellectt Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (231)
2022 (367)
2021 (259)
2020 (129)
Funding
Current Stage
Late StageCompany data provided by crunchbase
